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Warming Mattress Versus Polyethylene Wrapping to Prevent Hypothermia in Preterm Newborns.

This study has been completed.
Sponsor:
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00603837
First received: December 19, 2007
Last updated: October 12, 2009
Last verified: October 2009
History of Changes
  Purpose

Mean axillary temperatures, taken during NICU resuscitation upon admission to the NICU, will not differ between VLBW babies who are occlusively wrapped and very low birth weight (VLBW) babies who are placed on thermal warming blankets.


Condition Intervention
Hypothermia
 Device: NeoWrap
Device: InfaTherm

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Thermal Defense of Extremely Low Gestational Age Newborns (ELGANs) During Resuscitation: Exothermic Mattresses vs. Polyethylene Wrap

Resource links provided by NLM:

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:
  • Neonatal Intensive Care Unit (NICU) Admission Temperature [ Time Frame: At time of admission to the NICU - usually within 10-15 min of birth ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: May 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blanket
This arm includes those Extremely low gestational age newborns (ELGANs) who are to be placed on a sodium acetate warming blanket after delivery.
 Device: InfaTherm
A gel blanket containing a sodium acetate-based medium that, when activated, becomes exothermic and provides heat.
Experimental: Wrap
This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
 Device: NeoWrap
This is a polyethylene wrap that will be placed around the ELGAN from the neck down to prevent heat loss.

  Eligibility

Ages Eligible for Study:   24 Weeks to 28 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants in this study will be selected from the inborn population at University Hospital. Eligible patients will be selected from the group of babies with estimated gestational ages of 24-28 weeks and <1250g.

Exclusion Criteria:

  • Congenital anomalies with open lesions such as meningomyelocele, or omphaloceles
  • Blistering skin conditions

  • Resuscitation not performed secondary to infant being below limits of viability as assessed by the in-house attending physician (specifically, according to current NRP recommendations):

    • Where gestation, birth weight, and/or congenital anomalies are associated with almost certain early death, and unacceptably high morbidity is likely among the rare survivors, resuscitation is not indicated. Exceptions may be made based on parental desires.

      • Newborns with confirmed gestation age of less than 24 weeks or birth weight less than 400 grams
      • Anencephaly
      • Confirmed Trisomy 13 or Trisomy 18 syndrome
      • Meconium staining of amniotic fluid
      • Birth assessment of gestational age > 28 weeks or >1250 grams
      • Maternal temp >38 degrees C around the time of delivery.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00603837

Locations
United States, Oklahoma
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
Principal Investigator: Douglas Dannaway, MD University of Oklahoma
Study Director: Parker L Simon, DO, MPH University of Oklahoma
Study Chair: Marilyn Escobedo, MD University of Oklahoma
  More Information

No publications provided

Responsible Party: Douglas C. Dannaway, Oklahoma University Health Science Center
ClinicalTrials.gov Identifier: NCT00603837     History of Changes
Other Study ID Numbers: 13223
Study First Received: December 19, 2007
Results First Received: July 24, 2009
Last Updated: October 12, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Oklahoma:
Hypothermia
Prevention
ELGANs(Extremely low gestational age neonates)
Polyethylene Wrap
Sodium Acetate Transport Mattress

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on June 13, 2013